Solna, Sweden, September 24, 2018. Affibody AB (“Affibody”), a clinical stage biopharmaceutical company developing a portfolio of innovative drug projects, today announced that a major Nordic study (“Affibody-3”) will begin using Affibody’s PET imaging agent ABY-025. ABY-025 is a novel Affibody® molecule imaging tracer that with high precision can identify HER2 status in breast cancer patients. The researchers will be investigating a new ABY-025 based method developed at Uppsala University and the PET center at Uppsala University Hospital that has the potential to improve personalized breast cancer treatment.

”Since 2015, we have performed two smaller studies at Uppsala University Hospital with more than 20 patients showing very promising results. If we can demonstrate that the method works in larger scale, we believe it can quickly become a new “gold” standard worldwide. This would mean that difficult and stressful biopsies can be avoided for many breast cancer patients,” says Dr. Henrik Lindman, Physician at the Oncology Clinic, Uppsala University Hospital, who is running the study together with Dr. Jens Sörensen, Physician at the PET center in the hospital.

In patients with so-called HER2-positive breast cancer, a large amount of the HER2 protein is present on the surface of the cancer cells. The more concentrated the protein, the more aggressive the disease. The new PET method involves a small protein-tracer, ABY-025, labeled with radioactive gallium. This procedure is done at the PET center at Uppsala University Hospital. ABY-025 is administered to the patient, finding and attaching to the HER2 protein. The PET camera then records the tracer signals and calculates the patient’s exact HER2 status, enabling the physician to prescribe medication more accurately.

“Several drugs effective against HER2 positive breast cancer have been available many years now. However, when selecting treatment, it is extremely important to know if the woman has HER2-positive metastases and how much HER2 protein is present on the cell surface. Our new method has two major advantages – you do not have to take tissue samples to get answers, an unpleasant experience for the patient, and we can also simultaneously map all tumors in the body,” says Dr. Lindman.

“We are very proud of the way by which the ABY-025 development is conducted. The unique partnership that Affibody has with the principle investigators of Affibody-3 reflects our corporate ambition to build an extensive network of renowned researchers and clinicians in order to be able to fully capture the value of our proprietary platforms. We look forward to continue to build more such relationships”, said David Bejker, CEO of Affibody.

About Affibody-3

Affibody-3 is a pan-Nordic clinical study led from Uppsala University Hospital. In total, 120 women with breast cancer from 7-8 hospitals in Sweden, Denmark and Finland will be included in the study. Eligible patients should have HER2 positive or borderline HER2 positive, breast cancer with proliferation in the body or only in the breast. The purpose is to find out if the patients have HER2-positive tumors with the aid of a radioactively labeled tracer, ABY-025, and PET camera, something which is of great importance for the correct choice of treatment.

About ABY-025

The PET imaging agent ABY-025 is based on an Affibody® molecule that binds strongly to HER2. The high affinity and rapid clearance of ABY-025 from blood and normal organs allows HER2 assessment within hours.

Affibody is a clinical stage Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

The company operates a focused experimental medicine model and currently has four clinical or late stage preclinical proprietary programs. The first three are therapeutic programs that targets psoriasis, B-cell driven autoimmune diseases, and liver diseases respectively. The fourth program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

In addition, to its portfolio of innovative drug projects the company offers the half-life extension technology, Albumod™, for outlicensing.